The Indian subcontinent deserves to be considered by pharmaceutical or biotech firms examining clinical trial locations, and veteran industry players may be surprised to learn India is already a leading destination for global clinical trials with significant growth taking place in the biotech sector. Prime opportunities exist for all phases of clinical trials due to a confluence of factors in the world’s largest democracy.
The government of India has focused on enhancing healthcare policies and programs to a population with huge unmet medical needs. Medical infrastructure in India’s urban areas is already comparable to global averages and recently the government has been focused on making India more attractive for global trials.
According to Indian market expert Vanaja Krishnan, Managing Director with George Clinical, the reduced clinical trial approval time period of only three months, the abundance of treatment-naive patients and the corresponding faster accrual of patients to studies at lower costs all help warrant serious examination of India for clinical trials.
“Since most of the population receives limited government or insurance reimbursements, clinical trials are a great way for patients to gain access to novel therapies that they otherwise could not access,” Krishnan states. “Data collected in India is accepted by global regulatory agencies like FDA, EMEA, and TGA and inclusion of Indian population in a global trial helps avoid repeat clinical trials for marketing in India and faster processing of marketing applications.”
With the highest disease burden in India being in non-communicable diseases, there is a tremendous opportunity for contributing data on chronic conditions such as cancer. India has productive clinical trial sites including the availability of highly qualified, trained Investigators. The quality and reliability of trial data generated is equivalent to other globally conducted trials and past trials have enjoyed a high rate of subject recruitment.
“There is a huge potential for cost savings for global pharma organizations by conducting clinical trials in India vs. more traditional destinations,” Krishnan adds. “There is now an approachable regulatory body with a competent review system. Decisions on trial approval are completed by an unbiased team of experts in relevant therapeutic areas,” she notes.
Research staffs are typically competent in English and medical records and research documents are recorded in English. Internationally acclaimed key opinion leaders exist in the country for most of the therapeutic areas. Treatment protocols sit in line with global standards.
For those in the West, common misconceptions have dogged doing business in India for years. Perceptions that the clinical trial environment is unpredictable, complex and ambiguous; that data quality is poor or saddled with research fraud; or there is general lack of a regulatory process to oversee and ensure data quality all have been wrongly cited as concerns about the market.
“In fact, a client should expect trial work to be carried out with the same high quality of other regions we operate in, adhering to GCP E6 (R2), highly stringent Indian regulations and FDA/EMEA rules when as applicable,” Krishnan offered.